BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET GUARD

    MDR report key: 25077198 · Received May 5, 2026

    Report

    Report Number
    8021545-2026-06010
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 21, 2025
    Report Date
    April 22, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6). NAME: MEDTRONIC MINIMED COUNTRY: UNITED STATES OF AMERICA STREET: 18000 DEVONSHIRE STREET CITY: NORTHRIDGE STATE, PROVINCE OR TERRITORY: CALIFORNIA POST OFFICE OR ZIP CODE: 91325. IMDRF CAUSE INVESTIGATION CODE: CODE B24 IS NOT AVAILABLE IN DATABASE TO CAPTURE EVENT HISTORY LOG REVIEW ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS H11: INVESTIGATION SUMMARY COMPLAINT INVESTIGATION RESULTS: REVIEW OF COMPLAINT RECORD DATABASE (B)(4) EVENT DESCRIPTION AND ALL AVAILABLE INFORMATION WAS COMPLETED, AND LOT NUMBER 6010943 WAS PROVIDED. COMPLAINT WAS CLASSIFIED UNDER MALFUNCTION CODE: LEAK BETWEEN TUBING AND SITE CONNECTOR - TRACE MOISTURE / MINOR WETNESS A QUERY WAS RUN IN THE ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) ON 22-APR-2026 AGAINST "LOT NUMBER" "6010943" AND SIMILAR MALFUNCTION CODES: LEAK BETWEEN TUBING AND SITE CONNECTOR - TRACE MOISTURE / MINOR WETNESS, LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE), TUBING CONNECTOR IS CRACKED, SPLIT, DEFORMED, LEAKAGE MAY OCCUR. NO RECORDS WERE IDENTIFIED FOR THIS LOT AND SIMILAR RELATED ISSUES. A NONCONFORMING REPORTS (NCR)/CORRECTIVE AND PREVENTIVE ACTION (CAPA) QUERY SEARCH WAS RUN IN THE EQMS SYSTEM PERFORMED ON 22-APR-2026 AGAINST "LOT/BATCH NUMBER" "6010943". NO RECORDS WERE FOUND. BATCH RECORD REVIEW: SUB ASSEMBLY BATCH RECORD WITH LOT 4M03897 AND 4M03895 FOR THE MAIN BATCH RECORD WITH LOT 6010943 WERE REVIEWED. REVIEW OF THE SUB-ASSEMBLY DOCUMENTATION SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION OF COMPLAINT INVESTIGATION: LOT NUMBER 6010943 WAS PROVIDED, HOWEVER, AS THE COMPLAINT IS CATEGORIZED AS REPORTABLE AND NO ISSUES WERE FOUND DURING EQMS SEARCH AND BATCH RECORD REVIEW: NO VISUAL INSPECTION IS REQUIRED TO BE PERFORMED. NO RETAIN SAMPLE TESTING IS REQUIRED TO BE CONDUCTED. NO FURTHER ASSESSMENT WILL BE MADE REGARDING POTENTIAL PRODUCT PERFORMANCE ISSUES, COMPONENT INTEGRITY, OR MANUFACTURING DEFECTS. CAPA DETERMINATION: BASED ON THE AVAILABLE INFORMATION, NO FURTHER INVESTIGATION IS REQUIRED NOR CAPA PLAN IS NEEDED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING (MONTHLY TRIPS AND ALERTS). SUMMARY CONCLUSION: BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION HAS BEEN PERFORMED, AND THE COMPLAINT COULD NOT BE CONFIRMED AS ANALYZED. THEREFORE, THE COMPLAINT IS CLOSED BASED ON THE EVENT DESCRIPTION AND ALL INFORMATION MADE AVAILABLE. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 8021545 MANUFACTURING SITE: 8021545.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INFUSION SET LEAKAGE AT THE QUICK RELEASE ON (B)(6) 2025 AND THE INFUSION SET WAS IN USE FOR SIXTEEN HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285860 INSET GUARD SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S MMT-431AG600 6010943

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown